510(k) · Cleared
ClearedKLS Martin 3DX External Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Feb 27, 2004 as substantially equivalent to K994154 (KLS-Martin L.P., 2000) and 3 other predicates after a 60-day review. Its family tree reaches back 3 generations to 1986. 3 later devices descend from it.
- Decided
- Feb 27, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K864403 (1986). 9 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK864403 Monticelli Spinelli External Fixation SystemHowmedica Corp. · 1986
- 2 generations backK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
- 1 generation backK981362 Synthes (Usa) External Multi Vector Mandible DistractorSynthes (Usa) · 1998
- This deviceK034027 KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004
- Descendant · cites it directly · 2 of its ownK063792 Osteomed External Mandibular Distraction SystemOsteomed LP · 2007
- Descendant · 2 generations on · 1 of its ownK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
- Descendant · 3 generations on · 0 of its ownK230211 CranioXpandKLS-Martin L.P. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864403 | Monticelli Spinelli External Fixation System | Howmedica Corp. | 1986 | — |
| −2 | K960297 | Mandibular Bone Distractor II | Howmedica Corp. | 1996 | — |
| −1 | K981362 | Synthes (Usa) External Multi Vector Mandible Distractor | Synthes (Usa) | 1998 | — |
| 0 (this device) | K034027 | KLS Martin 3DX External Distraction System | KLS-Martin L.P. | 2004 | — |
| +1 | K063792 | Osteomed External Mandibular Distraction System | Osteomed LP | 2007 | — |
| +2 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
| +3 | K230211 | CranioXpand | KLS-Martin L.P. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQN device
- #1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994154 | Mod Line of Molina Distractors, 51-600 SeriesSummary page 1…straction System Classification Name and Number: Plate, Bone (CFR 872.4760) Regulatory Class: Class II Predicate Devices: KLS Martin Molina Distractor (K994154) Howmedica Inc. Mandibular Bone Distractor II (K960297)… | 2000 |
| * | K960297 | Mandibular Bone Distractor IISummary page 1…Predicate Devices: KLS Martin Molina Distractor (K994154) Howmedica Inc. Mandibular Bone Distractor II (K960297) Synthes External Multi Vector Mandible Distractor (K981362)… | 1996 |
| * | K981362 | Synthes (Usa) External Multi Vector Mandible DistractorSummary page 1…Mandibular Bone Distractor II (K960297) Synthes External Multi Vector Mandible Distractor (K981362) Lorenz External Mandibular Distractor (K992873) Intended Use: The KLS-Martin 3DX External Dist… | 1998 |
| * | K992873 | Lorenz External Mandibular DistractorSummary page 1…Synthes External Multi Vector Mandible Distractor (K981362) Lorenz External Mandibular Distractor (K992873) Intended Use: The KLS-Martin 3DX External Distraction System is a bone stabilizer and lengtheni… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063792 | Osteomed External Mandibular Distraction System | 2007 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K063792 (Osteomed LP, 2007) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K994154.
How does its category compare?
All MQN devicesMQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 2025
MAUDE reports naming product code MQN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 77 | 0 | 5 |
| 2008 | 3 | 292 | 0 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 1 | — | 0 | 107 |
| 2013 | 0 | — | 0 | 179 |
| 2014 | 1 | — | 1 | 57 |
| 2015 | 1 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 87 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 108 |
| 2019 | 1 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 101 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KLS Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034027 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034027: KLS Martin 3DX External Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034027
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026